In ICH GCP which of the following are stated as points that the sponsor should consider regarding Auditing Procedures?

1) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports.

2) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s).

3) The observations and findings of the auditor(s) should be documented.

4) When required by applicable law or regulation, the sponsor should provide an audit certificate.

Which of the following is correct?

According to ICH GCP which of the following should an audit evaluate trial conduct and compliance with?

1) SOPs

2) GCP

3) Protocol

4) Applicable Regulatory Requirements

Which of the following is correct

ICH GCP states that a Sponsor Audit is independent and separate from which of the following?

1) Routine Monitoring

2) Regulatory Inspection

3) Quality Control Functions

4) Site Close Out Visit

Which of the following is correct?

According to ICH GCP when an investigator's/institution's participation is terminated because of serious and/or persistent noncompliance identified through monitoring or audit what should the sponsor do?

1) Ensure that all subjects involved in the trial at the specific site are followed up

2) Promptly notify the regulatory authority(ies)

3) Provide training to the investigational site staff

4) Ensure that all payments received by the investigator/institution are returned to the sponsor

Which of the following is correct?